Kornimate/medical-research-clean huggingface dataset:
candonilimab plus bevacizumab for patients with advanced hcc who progressed on a+t

Conditions: Hepatocellular Carcinoma

Summary: to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. however, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. candonilimab is a humanized bisspecific monoclonal antibody against pd-1/ ctla-4 igg1. candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. this single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * patients have received atezolizumab plus bevacizumab and the tumor have progressed. patients have not received other treatmets except for the atezolizumab plus bevacizumab. * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma candonilimab plus bevacizumab atezolizumab plus bevacizumab
psychosocial treatment for women with depression and pain

Conditions: Pelvic Pain; Depression

Summary: patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. while psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for patients with both conditions. interpersonal psychotherapy (ipt), an effective treatment for depression, has been adapted successfully for physically ill patients and demonstrates good adherence, treatment satisfaction, and depression outcomes. the investigators propose to test a modified form of ipt-p for depressed patients with co-morbid pain.


Eligibility criteria:
inclusion criteria: * major depression * chronic pelvic pain exclusion criteria: * current or past psychosis * moderate mental retardation or greater * active suicidal intent * active abuse of non-prescribed substances (\< 3 months) * current individual psychotherapy * current pregnancy * terminal illness * inability to communicate in english * men
predicting poor outcomes after primary knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: aim to identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis research question 1. can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets 2. what are the characteristics of patients with poor outcome after knee replacement 3. what can be done to improve the outcome of patients at risk of poor results

this is a retrospective analysis of a prospectively collected single centre database.

Eligibility criteria:
inclusion criteria: * primary knee arthroplasty * osteoarthritis exclusion criteria: * no consent for joint registry data collection
sensitivity and specificity of sars-cov-2 rapid antigen test compared to rt-pcr test

Conditions: Covid19; Rapid Antigen Test; SARS-CoV-2

Summary: this project aims to investigate the sensitivity and specificity of the rapid antigen test compared to rt-pcr test performed on samples from the nasopharynx and the anterior nasal cavity and the oropharynx, respectively.

the purpose of the study is to investigate the sensitivity and specificity of correct sars-cov-2 test results of nasopharyngeal swabs and swabs swabs from the anterior part of the nose examined by rapid antigen test (standard q covid-19 ag - test, sd biosensor inc.) compared with swabs from the oropharynx examined by rt-pcr test among citizens who have booked an appointment for a covid-19 test in one of testcenter denmark's test centers in the capital region.

Eligibility criteria:
inclusion criteria: * age \> 18 years * a booked appointment for a covid-19 test at one of testcenter denmark's test centers in the capital region exclusion criteria: * previously tested positive for covid-19 * non-fluent in danish
phase iii study of bay43-9006 in patients with advanced hepatocellular carcinoma (hcc) treated after transcatheter arterial chemoembolization (tace)

Conditions: Carcinoma, Hepatocellular

Summary: clinical trial of bay43-9006 in patients with hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * male or female * aged of 18 and over * advanced hepatocellular carcinoma exclusion criteria: * history of prior systemic chemotherapy * failure in vital organ

Keywords: hcc cancer liver cancer tace
comparing differing financial incentive structures for increasing antidepressant adherence among adults

Conditions: Depression

Summary: the investigators will test using financial incentives by leveraging decision-making biases to improve adherence to antidepressants among adults newly prescribed antidepressants. this study will compare the effects of usual care, increasing financial incentives, and decreasing financial incentives on daily antidepressant medication adherence and depression symptom control of non-elderly adults with major depressive disorder.

a three arm randomized controlled trial will compare interventions to promote antidepressant adherence. one hundred twenty adults with major depressive disorder (mdd) who are initiating antidepressant treatment will be randomized in equal proportion to 1) usual care, 2) usual care and an escalating daily financial incentive for 6 weeks, or 3) usual care and a de-escalating financial incentive for daily antidepressant adherence for 6 weeks. study patients will participate in three assessments over a 12 week period as well as passive monitoring of antidepressant daily adherence through a wireless electronic pill bottle over the same 12 week period. the primary outcome will be the number of antidepressant daily doses taken during the initial six weeks of treatment. the secondary outcome will be daily adherence during the next six weeks following the discontinuation of the intervention.

Eligibility criteria:
inclusion criteria: * prescribed antidepressant * plan to take antidepressant as prescribed * working cell phone that allows texting * score on phq-9 ≥ 10 exclusion criteria: * no antidepressant use in last 90 days * never been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder * not currently pregnant or breastfeeding * no other serious medical condition

Keywords: medication adherence
lumpectomy specimen margin evaluation with tomography and structured light imaging

Conditions: Breast Cancer Female

Summary: the purpose of this study is to test a new surgical imaging system called "structured light imaging (sli)." this system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. the current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. one in five women (in the us) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue. in this study, researchers hope that the new sli system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. if successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.

on the day of surgery, the surgeon will remove the patient's cancerous tissue, and then in a separate room near the operating room, imaging staff will test it with the structured light imaging system. the testing may take several extra minutes to capture the images. after this imaging, the surgeon will complete the surgery. following surgery, and per routine medical care, the patient's breast tumor tissue sample will be sent to dhmc's lab for testing. the patient will see her primary doctor for standard surgery follow-up. no additional imaging or testing will be required for this research study following the usual surgery.

Eligibility criteria:
inclusion criteria: 1. females 18 years of age or older. 2. histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy. 3. scheduled for breast conserving surgery in the dartmouth-hitchcock (dh) outpatient surgical center 4. ability to give an informed consent. exclusion criteria: 1. patients who will have an expected specimen size greater than the specimen holder (i.e. \> 10 x 10 x 5 cm). 2. prisoners and cognitively impaired adults.
targeted screening of at-risk adults for acute hiv-1 infection

Conditions: HIV

Summary: in this research, the investigators want to see if early detection of hiv infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent hiv infection. specific objectives: 1. what proportion of people presenting with these symptoms are hiv positive at the point of seeking urgent health care? 2. what proportion of those who test negative or where the result is unclear (one rapid test positive and one negative) at first rapid hiv testing, will test positive two weeks later? 3. what is the best way (sms, phone call or home visit) to remind people to come for the second test after two weeks? 4. will young adults who seek urgent health care for fever, body pains, diarrhoea or an std from pharmacies or health facilities find it acceptable to be invited for an hiv-1 test at the time of health care seeking? hypotheses 1. targeted screening for ahi among patients seeking health care for symptoms compatible with ahi or sexually transmitted disease (std) will identify ahi cases in more than 1% of those screened. 2. intense follow-up of patients evaluated for ahi will improve rates of repeat hiv-1 testing 2-4 weeks after initial health-care seeking, relative to standard practice (i.e., recommendation to return for testing on a given date).


Eligibility criteria:
inclusion criteria: * symptom score of 2 or more: confirmed fever (≥37.5 °c axillary), reported diarrhoea, or evidence of std (variable score=2); reported body pains, or report of more than one sexual partners in past 2 months (variable score=1) * resident in mtwapa or shanzu or planning to stay in mtwapa for approximately 4 weeks duration * willing to give locator information (including mobile phone number) * negative or unknown hiv status exclusion criteria: * patients not meeting inclusion criteria

Keywords: hiv-1 acute diagnosis pharmacies healthcare facilities
study of pharmacokinetics of a single iv dose of cb-238,618 in subjects with varying degrees of renal impairment compared to healthy subjects (mk-6183-001)

Conditions: Healthy Volunteers; Renal Impairment

Summary: the purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of mk-6183 (cb-238,618) in humans. the study will also assess the safety profile and tolerability of mk-6183 in healthy participants, participants with varying degrees of renal impairment (ri), or participants with end-stage renal disease (esrd) requiring hemodialysis (hd), based on estimated glomerular filtration rate (egfr).


Eligibility criteria:
inclusion criteria: * participants who are healthy; or who have mild, moderate, or severe ri; or who have esrd requiring hd. participants with esrd requiring hd should have been receiving hd 3 times per week for at least 3 months preceding the initial dose in this study exclusion criteria: * for healthy participants (group a): history or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, including clinically significant anemia, which in the opinion of the investigator would jeopardize the safety of the participant or the validity of the study results * for participants with ri (groups b to e): as above, except that ri and other medical conditions commonly associated with renal impairment (eg, hypertension, diabetes, which should be stable for at least three months preceding the initial dose of study medication in this study) are allowed * clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ecg), vital signs, or laboratory values, as judged by the investigator or designee. subjects with renal impairment should have clinical laboratory values consistent with their disease and approved by the investigator * evidence of clinically significant hepatic impairment including alanine aminotransferase or aspartate aminotransferase \>1.5 × upper limit of normal (uln) or bilirubin \>1 × uln * hemoglobin \<8 g/dl, unless considered stable and not clinically significant in the opinion of the investigator in subjects with esrd and on hd * participants with renal impairment who are not on a chronic stable drug regimen, defined as starting a new drug or changing dosage within 14 days prior to administration of study medication, except for drugs administered in relationship to hd * participants with fluctuating or rapidly deteriorating renal function (assessment of the stability of the subject's renal function will be determined by the investigator) * participant has a currently functioning renal transplant and/or has been on significant immunosuppressant therapy, as determined by the investigator, within the last 6 months
modelling internal hepatic movement with an external abdominal marker

Conditions: Patients With Liver Metastases From Colorectal Cancer

Summary: this study tests the feasibility and reproducibility of patient-specific motion models. these will be used for quantification of safe margin reduction. patient-specific motion models will be built by post-processing 4d mri data with non-rigid registration. by comparing these models between visits, model reproducibility will be assessed, and the methodology refined.

the study will use a real time position management (rpm) system for respiratory gating. the rpm system senses the respiration motion of the patient by tracking a pair of reflective markers on a lightweight "marker block" constructed of a synthetic material. this block is placed on the patient's abdomen. during radiotherapy, the beam is only switched on at pre-determined phases of respiration. the appropriate phase of respiration is determined by the rpm system. this implies a reliable correlation of external block motion to internal hepatic movement. this correlation is not a simple one, and requires "modeling".

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma compatible with primary disease in the colon or rectum * aged 18 years or older * unequivocal contrast-enhanced ct and/or mri evidence of malignant single or multiple metastases in the liver, metastases at other sites will not be an exclusion criterion * who performance status 0-2 and life expectancy of at least 12 weeks * informed written consent exclusion criteria: * pregnancy or breast feeding * evidence of ascites * patients unable for whatever reason to lie flat * patients unable to give fully informed consent * age\< 18 years
injection of 99mtc-nanocolloid and icg to identify, retrieve and qualify tdln in early-stage nsclc

Conditions: Early-stage Lung Cancer

Summary: the patient wil receive intra- or peritumoral injections of 99mtc-nanocolloid if malignancy is found during a navigation bronchoscopy. a spect/ct-scan will be made to image injections sites and sentinel lymph nodes (sln). if surgery takes place to treat the lung cancer, icg will be injected and fluorescent lymph nodes will be extensively assessed by a pathologist.

when malignancy is found during navigation bronchoscopy, study participants will receive intra- or peritumoral injections of 99mtc-nanocolloid. following, up to 2 spect/ct-scans will be made to assess drainage of the injected tracer to the lymph nodes. if patients undergo resection of the lung lesion, icg will be injected. the involved lung tissue will be removed, followed by routine complete lymph node dissection. the fluorescent lymph nodes will be more extensively evaluated by the pathologist.

Eligibility criteria:
inclusion criteria: * asa physical status 1-3; * lung lesion between 1 and 5 cm; * imaging-based disease free lymph nodes (n0); * patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon. exclusion criteria: * pregnancy; * inability to consent; * known or suspected allergy to 99mtc-nanocolloid or icg.

Keywords: sentinel lymph node procedure 99mtc-nanocolloid icg spect/ct-imaging
a study evaluate aqueduct's smart external drain

Conditions: Hydrocephalus; Hydrocephalus in Children; Tumor, Brain

Summary: to evaluate the performance characteristics of the smart external drain (sed) compared with standard evd drains in the hospital setting, specifically: * number, type and duration of staff interactions. * regulating and controlling icp and csf drainage. * maintaining system control with patient movement.

in this two day clinical trial, subjects will be observed on day 1 of study during their routine treatment and using their already existing evd. on day 2 of study; subjects will be switched to the smart external drain for monitoring and management of icp and csf

Eligibility criteria:
inclusion criteria: 1. stable neuro - examination on standard evd assessed as not clinically significant (ncs) by pi or delegated sub-i prior to study treatment. 2. gcs \> 13 (minimum of e3v5m5) prior to study treatment. 3. subject must be scheduled to have an evd placed as part of routine management and for a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of hydrocephalus) 4. age 5-80. 5. stable vital signs - blood pressure (systolic and diastolic), heart rate, respiratory rate and weight assessed as not clinically significant (ncs) and afebrile as per pi/sub-assessment. (stable vital signs will be re-assessed again prior to treatment with the sed on day 2) 6. able to perform and follow simple commands (ex: sit up in bed, lay down in bed) 7. pre-study ct/mri imaging stable per pi sub-i assessment post ventriculostomy. 8. able to stand 9. able to obtain consent exclusion criteria: 1. refractory icp or needing active icp management 2. unable to tolerate brief clamping of evd (\<5min) 3. unable to follow simple commands 4. unconscious 5. anticoagulant therapy 6. known bleeding diathesis 7. scalp infection 8. in the opinion of the investigator the subject is not a good study candidate
study of the pharmacokinetics and safety of asunaprevir in patients with kidney disease

Conditions: Hepatitis C

Summary: the purpose of the study is to determine how asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

primary purpose: other: the purpose of the study is to determine how asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

Eligibility criteria:
inclusion criteria: * group a: subjects with normal renal function * group b: patients with end stage renal disease * group c: patients with mild renal impairment * group d: patients with moderate renal impairment * group e: patients with severe renal impairment exclusion criteria: * history of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease * hepatitis b or c * human immunodeficiency virus (hiv) * recent gastrointestinal disease
optical coherence tomography (oct) based screening of esophagus and gastroesophageal junction

Conditions: Barrett's Esophagus

Summary: the specific aim of this study is to determine the accuracy of optical coherence tomography (oct) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (egd) procedure. the accuracy of results obtained using the developed oct imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .

three hundred consenting patients undergoing routine esophagogastroduodenoscopy (egd) procedures will be recruited for examination at the gastroesophageal junction with our developed oct imaging system. the patients will undergo a clinical egd procedure including endoscopic biopsy. the first step in the procedure follows the standard care with the performance of the surveillance endoscopy. the study experimental procedure will then begin. this study requires the use of a balloon . the balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. the endoscope is then removed, leaving the guide wire in place, and the oct balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the ge junction. the oct balloon will then be inflated and will remain in this fixed position throughout the entire procedure. once the oct imaging probe is in place, oct image data will be continuously collected over the length of the balloon(approximately 5 cm). it is expected that the total examination time including insertion and inflation of the oct balloon, oct imaging and removal of the oct balloon will add no more than 10 minutes to the total length of the egd.

Eligibility criteria:
inclusion criteria: * over the age of 18, * capable of giving informed consent, * are undergoing elective egd, and * if female are willing to take a pregnancy test exclusion criteria: * patients on oral anticoagulation medications, * with a history of hemostasis disorders and * patients that are pregnant

Keywords: barrett's esophagus oct imaging